Skip to main content

Useful Resources for Clinical Research

BayBiotech.NET
Hello All,

Here is a list of some resources related to Clinical Research and Regulatory Affairs, hope you will find them useful for your work! More to follow in my next blog….

Useful Resources

1. Directory of pharmaceutical industry-funded clinical trials, free and easy-to-use interface for patients and health professionals alike to ongoing clinical trials, clinical trial results and complementary information on related issues.
Link: http://www.ifpma.org/clinicaltrials

2. Registry of federally and privately supported clinical trials conducted in the United States and around the world.
Link: http://www.clinicaltrials.gov

3. Opportunities for public involvement in clinical research: People in Research helps members of the public make contact with organizations that want to actively involve them in clinical research.
Link: http://www.peopleinresearch.org

4. Regulatory Affairs Professional Society: society of professionals engaged in regulatory affairs.
Link: http://www.raps.org

5. National Institute of Child Health and Health Development: resource for clinical research related information.
Link: http://www.nichd.nih.gov/health/clinicalresearch/

6. Council For International Organizations Of Medical Sciences
Link: http://www.cioms.ch/index.html

7. FDA Good Clinical Practices: details on regulations around Good Clinical Practices as per FDA guidelines.

Link: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

8. International Organization of Standardization
Link: http://www.iso.org/iso/home.htm

9. International Conference on Harmonization
Link: http://www.ich.org/cache/compo/276-254-1.html

10. UK Clinical Research Collaboration: a partnership of organizations working to transform the environment for clinical research in the UK.
Link: http://www.ukcrc.org

11. UK Clinical Research Network: The UK Clinical Research Network (UKCRN) supports clinical research and helps to deliver clinical trials and other well designed studies across the UK.
Link: http://www.ukcrn.org.uk

12. Medical Research Council: Medical Research Council (MRC) has been conducting clinical trials to address important public health questions and improve clinical care.
Link: http://www.mrc.ac.uk

Comments

Popular posts from this blog

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...

Risk Based Clinical Monitoring

BayBiotech.NET FDA's recommendation of Risk Based Monitoring of Clinical Trials , as published in their Draft Guidance in August 2011. For the first time, FDA provided guidance on monitoring of clinical investigations in 1988 which was recently withdrawn, stated that the “most effective way” to monitor an investigation was to “maintain personal contact between the monitor and the investigator throughout the clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to effect meaningful communication with investigators other than through on-site visits.   This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying crit...

eCTD Submission Specifications

BayBiotech.NET The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. eCTD technical document format development was done by International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Details on the specification for the ICH eCTD can be found in the guidance document M2 eCTD: Electronic Common Technical Document Specification. Currently, eCTD is the preferred format for electronic submissions by U.S. Food and Drug Administration. Although originally the CTD and the eCTD were designed for marketing applications, they could apply equally to other submission types, including INDs, master files, advertising material, and promotional labeling. In June 2008, FDA has issued guidelines for organizing the electronic regulatory document filing using the eCTD tools. This guidance discusses issues related to the electronic submission of applications for hum...